Opioid REMS Requires Sponsors To Launch Prescriber Training CME Within 9 Months
This article was originally published in The Pink Sheet Daily
By the third year of continuing medical education efforts, FDA expects 60% of those who wrote a prescription for a long-acting/extended-release opioid in 2011 to receive training.
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Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.
FDA draft report on REMS standardization also suggests creating a patient counseling tool template for providers.
CME content must be developed without influence from drug companies, but FDA says it does not have the resources to write a blueprint for every risk management education program as it did for the opioid REMS.